510(k) K003965
K003965 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "MRI SAFE INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on March 16, 2001. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2001
- Date Received
- December 22, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type